GUEST COLUMNISTS

• January 2026 — CDMO Opportunities And Threats Report

  Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

• This Industrial Fungus Has Protein Expression Promise For Pharma

  Trichoderma reesei is well characterized for industrial uses. A Finnish research group is exploring it for pharmaceutical protein expression.

• Leveraging Conventional Therapeutics Skills For Cell And Gene Therapy

  Cell and gene therapies share fundamental objectives with conventional biologics. Their common challenges offer a natural starting point to solving downstream bottlenecks.

• Real-World Phase-Appropriate Control Lessons For mAb/ADC Manufacturers

  Effective mAb and ADC manufacturing control strategies evolve through the phases. These four principles should guide your strategy design as goals shift.

• High Specific Productivity For Leaner Sustainable Bioprocessing

  Improving specific productivity moves the goal beyond pumping out higher titers, but it demands a deeper understanding of cellular biology and protein expression.

• New ISPE Framework Targets Uncertainty In Pharma's AI Deployment

  International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.

• Facility Considerations When Retrofitting Legacy Sites For ADCs

  Antibody-drug conjugate manufacturing requires, among other things, unidirectional flow and air locks for people and materials. Facilities often lack these attributes.

• In Vivo's Biggest Threat — Comparison To Old Models

  In vivo CAR-T is not simply ex vivo without a manufacturing step. It is a different modality that relies on biological systems to regulate outcomes.